1E10 anti-idiotype vaccine, metastatic breast cancer, phase II

• Register: RPCEC
• Last refreshed on: 29 April 2013
• Main ID: RPCEC00000008
• Date of registration: 27/12/2010
• Primary sponsor: Center of Molecular Immunology (CIM)
• Public title: 1E10 anti-idiotype vaccine, metastatic breast cancer, phase II
• Scientific title: Active specific immunotherapy with 1E10 anti-idiotype vaccine to treat patients with metastatic breast cancer, phase II.
• Date of first enrolment: 15/09/2003
• Target sample size: 80
• Recruitment status: Closed
• URL: http://registroclinico.sld.cu/trials/RPCEC00000008-En
• Study type: Interventional
• Study design: Randomization: Randomized Controlled Trial Blinding: Double Blind Placebo: Active Assignment: Parallel Purpose: Treatment

Countries of recruitment

Cuba

Contacts

• Name: Amparo Macias Abraham
• Affiliation: Center of Molecular Immunology (CIM)

• Name: Amparo Macias Abraham
• Affiliation: Center of Molecular Immunology (CIM)

Key inclusion & exclusion criteria

Inclusion criteria: 1)Female patients with cyto- ’histological confirmed diagnostic of recurrent or Stage IV metastatic breast cancer 2)Patients that have received the oncospecific therapy according to the treatment guidelines established in the country and that have ended the different protocols in a time period of 4 weeks prior to entry in the trial. 3)Patient’s informed consent to participate in the investigation obtained. 4)Age = 18 years. 5)Patients with life expectancy = 6 months. 6)Performance Status according to WHO from 0 to 2. 7)Clinical laboratory parameters: a.-) Hematopoietic parameters: - Hb>100g/l, - Leucocytes>4 x 109cells/l - Granulocytes>2x109 cells/l, - Platelets> 100 x 109cells/ l. b.-) Liver (not exceeding the normal upper limit by three times), bilirubin: 17mol/l (LSN), ALAT: 40U/l (LSN), ASAT: 40U/l (LSN), alkaline phosphatase: 279U/l c.-) Kidney: serum creatinine: 132 mmol/l.
Exclusion criteria: 1.Patients with breast cancer in stage Iv or recurrent diseases that have received oncospecific therapy and have concluded the different protocols in a time period inferior to 4 weeks or greater than 4 weeks prior to entry in the trial. 2.Pregnant or breastfeeding patients. 3.Patients with prior history of demielinizing disease or inflammatory disease of the CNS or the peripheral nervous system. 4.Patients with previous malignancies except carcinoma in situ of cervix or skin cancer (not melanoma), treated properly. 5.Patients with acute or chronic infectious diseases. 6.Patients with acute allergic status or history of severe allergic reactions. 7.Patients with autoimmune diseases or chronic non-compensated diseases. 8.Patients who present the contralateral breast as the only site of metastatic disease.

Age minimum: 18 years
Age maximum: 80 years
Gender: Female

Health Condition(s) or Problem(s) studied

Breast carcinoma in stage IV or progressive metastatic disease

Intervention(s)

Study group. Anti-idiotype vaccine 1E10. The patients will receive 15 immunizations (1 ml per immunization, at a concentration of 1 mg/ml of antiserum 1E10) intradermally at intervals of fourteen days the first 5 immunizations and monthly thereafter until all 10 doses remaining. Control group: Placebo. Scheme identical to the study group. In addition to the vaccine preparation or placebo, patients may receive concurrent therapy with Tamoxifen.

Primary Outcome(s)

Survival time and time to progression. Measuring Time: 18 and 24 months.

Secondary Outcome(s)

Humoral Immune Response, toxicity and clinical response. Measuring time: 18 and 24 months

Secondary ID(s)

IIC RD-059

Source(s) of Monetary Support

Government funds

Secondary Sponsor(s)

Not applicable